Veterinary Medicines

ORAMEC Drench for Sheep 0.8 mg/ml

Authorised
  • Ivermectin
Download as PDF

Product identification

Medicine name:
ORAMEC Drench for Sheep 0.8 mg/ml
Active substance:
  • Ivermectin
Target species:
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ivermectin
    0.80
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Sheep
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • The product is packaged in polyethylene backpacks containing 5 litres
  • The product is packaged in polyethylene backpacks containing 2.5 litres
  • The product is packaged in polyethylene jerrycans containing 1 litre.
  • The product is packaged in polyethylene backpacks containing 1 litre

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France SCS
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10454/072/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/02/2025
Download

ie-puar-np-600000064292-oramec-drench-for-sheep-08-mgml-en.pdf

English (PDF)
Published on: 23/02/2025
Download